Area Quality Specialist

Jobtailor; Bogotá ciudad; Híbrido; COP 70.000.000 - 130.000.000; Jornada completa

Descripción de la vacante

Jobtailor in Bogota, Colombia is seeking a Quality Management professional to govern the ENOVIA document control system, ensure review-step compliance, and drive continuous improvement.

You will lead internal audits, CAPA development, risk assessments, and regulatory inspections, while partnering with the Technical Director to ensure GMP, GDP, and Colombian regulatory compliance. Hybrid work at the Solventum office and the 3PL in Cundinamarca with up to 10% travel.

Formación

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Healthcare, or related field.
• Minimum of three years of experience maintaining QMS and GDP within medical devices and/or pharmaceutical environments.
• Intermediate to advanced English proficiency for global communications.
• Strong knowledge of medical device and pharmaceutical regulations, including GMP and CAPA practices.

Responsabilidades

• Manage and govern the ENOVIA document control system ensuring review-step compliance.
• Monitor, analyze, and drive performance against key quality KPIs.
• Lead cross-functional investigations and manage CAPA development, implementation, and effectiveness monitoring
• Conduct annual site risk assessments
• Develop, execute, and oversee internal audit and self-inspection programs
• Support external audits according to Technical Director instructions and global procedures
• Deliver employee training and qualification programs on QMS requirements and quality processes
• Partner with the Technical Director to ensure compliance with regulatory, quality, and operational requirements
• Support product release activities, including oversight of Certificates of Analysis and related quality documentation
• Manage change control processes, including documentation, impact assessment, implementation, and effectiveness tracking
• Act as designated backup for the Technical Director
• Undertake additional responsibilities assigned by management to support organizational priorities and continuous improvement

Conocimientos

QMS management

GDP knowledge

Regulatory affairs

Internal audits

CAPA management

Data analysis

Change control

Regulatory inspections

IMS

GMP

Employee training

Risk assessment

Documentation compliance

Educación

Bachelor's Degree in Pharmacy

Pharmaceutical Sciences

Life Sciences

Healthcare

Descripción del empleo

• Manage and govern the company’s ENOVIA document control system, ensuring review-step compliance with local requirements


• Monitor, analyze, and drive performance against key quality KPIs


• Lead cross-functional investigations and manage CAPA development, implementation, and effectiveness monitoring


• Conduct annual site risk assessments


• Develop, execute, and oversee internal audit and self-inspection programs


• Support external audits according to Technical Director instructions and global procedures


• Deliver employee training and qualification programs on QMS requirements and quality processes


• Partner with the Technical Director to ensure compliance with regulatory, quality, and operational requirements


• Support product release activities, including oversight of Certificates of Analysis and related quality documentation


• Manage change control processes, including documentation, impact assessment, implementation, and effectiveness tracking


• Act as designated backup for the Technical Director


• Undertake additional responsibilities assigned by management to support organizational priorities and continuous improvement

Requirements

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Healthcare, or a related field, completed and verified before the start date


• Minimum of three (3) years of experience maintaining Quality Management Systems (QMS) and Good Distribution Practices (GDP) within Medical Devices and/or Pharmaceutical environments


• Intermediate to advanced English proficiency, with the ability to communicate effectively in a global environment


• Strong knowledge of Medical Device and Pharmaceutical regulations, including Good Storage, Distribution, and Transportation Practices


• Experience conducting internal audits, risk assessments, CAPA management, change controls, and regulatory inspections


• Statistics and data analysis for quality performance monitoring and continuous improvement


• Experience in Regulatory Affairs within regulated healthcare industries


• Knowledge of Integrated Management Systems (IMS), Good Manufacturing Practices (GMP), and Corrective and Preventive Actions (CAPA)


• Familiarity with Colombian regulatory requirements for Medical Devices and Pharmaceuticals


• Ability to work in a hybrid arrangement at the Solventum office and the 3PL in Cundinamarca


• May include up to 10% travel in country

Core Competencies

Demonstrates expertise in managing Quality Management Systems (QMS) and ensuring compliance with regulatory requirements in the pharmaceutical and medical device sectors. Proficient in conducting audits, risk assessments, and CAPA management to drive continuous improvement and maintain quality standards.

Highest-signal resume keywords

• Quality Management Systems (QMS)


• Good Distribution Practices (GDP)


• Regulatory Affairs Experience


• Internal Audits and Risk Assessments


• Corrective and Preventive Actions (CAPA)

ATS Optimization Keywords

Hard Skills

• Quality Performance Monitoring


• Data Analysis


• Change Control Management


• Regulatory Inspections


• Integrated Management Systems (IMS)


• Good Manufacturing Practices (GMP)


• Employee Training on QMS


• CAPA Development and Implementation


• Risk Assessment


• Documentation Compliance

Soft Skills

• Effective Communication


• Cross-Functional Leadership


• Organizational Skills


• Problem-Solving


• Collaboration

Certifications & Qualifications

• Bachelor’s Degree in Pharmacy


• Pharmaceutical Sciences


• Life Sciences


• Healthcare

Industry Keywords

• Medical Devices


• Pharmaceutical Regulations


• Colombian Regulatory Requirements


• Good Storage Practices


• Good Transportation Practices